Best method requirement continues to wreak havoc

In Sandvik Intellectual Property AB v Quarry Mining & Construction Equipment Pty Ltd [2017] FCAFC 138 (“Sandvik”) the Full Federal Court recently revisited the requirement for patent applicants to disclose in their specifications the best method known to them at the filing date for performing the claimed invention. Additionally, the Australian Patent Office has considered the application of the ‘best method’ requirement in a number of recent decisions, including Smith Light Pty Ltd v Golight Pty Limited[2016] APO 37 (“Smith”); Merial New Zealand Limited v Jurox Pty Ltd [2017] APO 5 (“Merial”); and Kineta, Inc. [2017] APO 45 (“Kineta”).

Australia’s best method requirement had received little judicial consideration prior to the Full Federal Court’s 2016 decision in Les Laboratoires Servier v Apotex Pty Ltd[2016] FCAFC 27. In that case, the Full Court held the patent to be invalid for failing to meet the best method requirement, and subsequent attempts to amend the specification to remedy the deficiency were declined. While the application of Australia’s ‘best method’ requirement ultimately turns on the facts of a given case, the Full Court’s decision in Servier highlighted the fatal consequences of failing to include a description of the best method in patent specifications filed in Australia – a clear distinction from other jurisdictions. Application of the best method requirement in Australia also now seems to differ from the way the best method (or best mode) requirement has been applied in the United States. In particular, even when the claimed invention is a product, it may be necessary in particular circumstances to disclose the best way of making that product known to the applicant at the filing date.

A full discussion of Les Laboratoires Servier v Apotex Pty Ltd[2016] FCAFC 27 is available here.

The patent at issue in Sandvik was directed to an extension drilling system for use in drilling bores. Evidence was presented at first instance that one of the “real issues” to be addressed during development was the design of an effective water seal. However, the technical drawings, which pre-dated the filing of the complete application and which described an improved sealing arrangement for use with the drilling system, were not disclosed in the specification at filing. As a consequence, the judge at first instance found that the omitted sealing arrangement was not merely a minor feature, but was instead the superior design.

On appeal, Sandvik highlighted that the way in which the invention as claimed solved the problem was not directed to any particular form of water seal. However, the Full Federal Court rejected this argument, upholding the decision of the primary judge that the best method involved the use of a specific type of water seal which was not disclosed in the specification at filing. With regard to the omitted seal, the Full Court restated the primary judge’s findings that:

We are not here dealing with some minor or incidental dimension of what was perceived by the inventors as the best method of performing the invention: as Mr Weaver said, this sealing aspect was ‘a real issue which needed to be overcome’.

In considering the ‘best method’ requirement, the Full Court clarified that the correct approach is to:

Identify the invention described (not claimed) in the specification as a whole;

Determine whether the allegedly omitted part is necessary and important to perform the invention (or carry it into effect); and

Where the specification purports to address the best method requirement, determine whether the Applicant described the best embodiment known to it.

The decision in Sandvik again highlights that patent applicants in Australia must ensure that the description of embodiments in a patent specification is updated prior to filing. Sandvik’s omission of the superior water seal rendered the patent invalid, even though the sealing member did not form part of the invention as claimed.

The patent application at issue in Smith was directed to a portable light assembly. Acceptance of the application was opposed before the Australian Patent Office on a number of grounds, including failure to disclose the best method. In the proceedings, the opponent argued that “optimised design arrangements relating to for example, the specific locking and release means, and the electronic and material specifications represent the best method of performing the invention”, and the applicant had withheld these design arrangements at the time of filing. Drawing on the Full Court’s findings in Servier, the opponent suggested that the vague disclosure of a ‘locking means’ were no more specific and akin to the omitted salification methods utilised and known to the patentee at the filing date in the Servier case.

However, the Delegate found that the invention as described in the whole of the specification resided in the interrelationship between the claimed components rather than the individual elements themselves. As such, the Delegate held that any lack of description of the specific features identified by the Opponent did not result in the application falling foul of the best method requirement, as those individual features were not of themselves the described invention.

At issue in Merial were three related applications claiming anthelmintic compositions. During opposition proceedings before the Patent Office, the opponent argued (and Jurox did not counter) that the best method of performing the invention involved the use of a product called “Q-drench”, the method of preparation of which was known to the applicant before the filing date.

While the specification included various examples of the preparation of anthelmintic compositions, in evidence presented to the Delegate it was demonstrated that the preparation of Q-Drench specifically required that the pH be adjusted to 5.3 to 5.5 on the day of preparation. None of examples however described such a pH adjustment step.

In light of this evidence, the Hearing Officer concluded that all three applications “lack[ed] the critical steps (pH adjustment) which [were] part of the best method of performing the invention which was known to the applicant at the filing date.” But in this case, and in view of the fact the applications were all subject to the more lenient amendment provisions prior to the Raising the Bar Act (that came into effect in April 2013), the Officer indicated that the three applications could be amended to include the missing information about pH adjustment.

While the decision was initially appealed to the Federal Court, the matter was settled prior to being heard. The amendments were subsequently allowed and the patents proceeded to grant.

The patent application at issue in Kineta was directed to chemical compounds and their use for treating viral infections, such as RNA viral infections. During the course of examination, the Examiner formed the view that the specification failed to disclose the best method of performing the invention. The applicant requested a hearing before the Patent Office to resolve the matter.

Kineta’s application was subject to the more stringent provisions of the Raising the Bar Act. Prior to the introduction of the Raising the Bar Act, the ‘best method’ requirement was not a ground of examination. However, with the new legislation, Australian Examiners may now consider whether the best method known to the applicant of performing the invention is disclosed in the complete specification.

The single outstanding ground of objection considered by the Hearing Officer was whether the best method of performing the invention had been disclosed. The complete specification detailed a number of compounds which were simply described as “available”, together with data relating to their associated antiviral activities.

In considering the invention disclosed in the specification, the Hearing Officer suggested the invention lay both in the identification of new compounds and their use in the treatment of viral infections. However, the examples recited in the complete specification did not provide any information about how the compounds might be prepared.

Kineta advanced two alternate arguments with respect to best method. The first argument was that a best method is implicitly disclosed as a person skilled in the art would have understood how to prepare the compounds. Alternatively, Kineta argued it had not withheld any information about the preparation of the compounds, since they were purchased from a third party contractor and not prepared by the applicant.

Despite expert evidence presented by Kineta, the Hearing Officer concluded with regard to the first argument that a person skilled in the art would not have appreciated how to prepare any of the compounds from a reading of the specification in the light of the common general knowledge. With regard to the second argument, the Hearing Officer acknowledged that Kineta was not informed as to how the compounds they had obtained were prepared. He did find, however, that the applicant was aware that the compounds could be purchased from a contractor, but that this information was not included in the specification. As such, the Hearing Officer maintained that the applicant failed to disclose the only method (and thus the best method) that the compounds could be purchased from the third party contractor.

Under the Raising the Bar Act, it is not possible to add matter to a specification and as such, Kineta had little recourse to address the deficiencies in their application. However, it is noted that two new pending divisional applications were subsequently filed, the specifications of which have been updated to include both a general description of the synthesis of the compounds as well as details of the third party contractor who originally prepared the compounds. The new divisional applications are yet to be examined by the Patent Office.

Key lesson

These cases serve as another reminder of the fatal consequences for patentees who fail to satisfy the best method requirement under Australian patent law. In view of the more stringent standards for amendment under the Intellectual Property Laws Amendment (Raising the Bar) Act 2012, as highlighted by the Kineta case, it is paramount that patent applicants in Australia ensure the best method known to them of performing the invention is included in the specification at the time of filing to avoid the ticking time bomb that is the ‘best method’ requirement under Australian law.